SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

April 11, 2024 updated by: Medtronic Vascular

The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.

Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Principal Investigator:
          • Antony Walton, MD
        • Contact:
        • Sub-Investigator:
          • Yusuke Sata, MD
        • Sub-Investigator:
          • Liam Guiney, MD
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Dobney Hypertension Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carl Schultz, MD
        • Sub-Investigator:
          • Sharad Shetty, MD
  • Belgium
      • Brugge, Belgium, 8000
        • Recruiting
        • AZ Sint Jan Brugge-Oostende av
        • Principal Investigator:
          • Jan van der Heyden, Dr
      • Genk, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost Limburg - Campus Sint-Jan
      • Gent, Belgium, 9000
      • Liège, Belgium, 4000
        • Recruiting
        • Chc Montlegia
        • Contact:
          • Pieter-Jan Palmers
          • Phone Number: +3243554180
        • Principal Investigator:
          • Pieter-Jan Palmers
    • Oost - Vlaanderen
      • Aalst, Oost - Vlaanderen, Belgium, 9300
        • Recruiting
        • Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Rosseel, MD
  • France
      • Bordeaux, France, 33 000
        • Recruiting
        • Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
        • Contact:
        • Principal Investigator:
          • Antoine Cremer
        • Sub-Investigator:
          • Julien Doublet
        • Sub-Investigator:
          • Philippe Gosse
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie Salpetriere
        • Contact:
          • Gilles Montalescot, MD, PhD
        • Principal Investigator:
          • Gilles Montalescot, MD, PhD
  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Uniklinik Erlangen
        • Contact:
          • Phone Number: 091318536207
        • Principal Investigator:
          • Roland Schmieder, Prof.
      • Gießen, Germany, 35390
        • Recruiting
        • Justus-Liebig-Universität Gießen
        • Principal Investigator:
          • Oliver Dörr, MD
      • Homburg, Germany
        • Recruiting
        • Universitatsklinikum des Saarlandes
        • Contact:
          • Felix Mahfoud, MD
      • Leipzig, Germany, 04289
      • Lübeck, Germany, 23560
        • Recruiting
        • Sana Kliniken Lübeck GmbH
        • Contact:
        • Contact:
          • Tolga Agdirlioglu
        • Principal Investigator:
          • Prof. J. Weil
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Hippokration General Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Tsioufis Konstantinos
  • Monaco
      • Monaco, Monaco, 98000
        • Recruiting
        • Centre Hospitalier Princesse Grace
        • Contact:
        • Principal Investigator:
          • Atul Pathak, MD
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
        • Recruiting
        • Zuyderland Medisch Centrum Heerlen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saman Rasoul, Dr
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Universtiy Medical Center
        • Contact:
        • Principal Investigator:
          • Joost Daemen, MD, PhD
  • Sweden
      • Stockholm, Sweden, 18288
        • Recruiting
        • Danderyd Sjukhus
        • Principal Investigator:
          • Thomas Kahan
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
        • Contact:
          • Katharine New
        • Sub-Investigator:
          • Prof. Adrian Banning
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham (UAB) Hospital
        • Principal Investigator:
          • Mustafa Ahmed, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hussein Abu Daya, MD
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Banner Heart Hospital
        • Principal Investigator:
          • Jaskamal Kahlon
        • Contact:
          • Robert Flynn
          • Phone Number: 480-412-6859
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Abrazo Arizona Heart Hospital/Biltmore Cardiology
        • Principal Investigator:
          • Timothy Byrne
        • Contact:
        • Sub-Investigator:
          • Akram Ibrahim
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Taral Patel, MD
        • Sub-Investigator:
          • Mayurkumar Bhakta, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Arkansas Cardiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dwight Chrisman, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Memorial Hospital
        • Contact:
          • Janet Lawrence, BA, CCRC
          • Phone Number: 858-824-4168
        • Contact:
          • Christina Nava, CCRP
          • Phone Number: 858-824-5244
        • Principal Investigator:
          • Paul S. Teirstein, MD, FACC
        • Sub-Investigator:
          • Curtiss T. Stinis, MS, FACC, FSCAI
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Hospital and Clinics
        • Contact:
        • Contact:
        • Principal Investigator:
          • David P. Lee, MD
        • Sub-Investigator:
          • Alan C. Yeung, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevin Rogers, Dr
        • Sub-Investigator:
          • Bricker Rory, Dr
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Ingrassia, MD
        • Sub-Investigator:
          • Mohamad Firas Barbour
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nelson Bernardo, MD
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular Consultants
        • Contact:
        • Principal Investigator:
          • Douglas Spriggs, MD
        • Sub-Investigator:
          • Donald Kikta, MD
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • BayCare Health System
        • Principal Investigator:
          • Parag Patel
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Principal Investigator:
          • Nipun Arora, MD
        • Contact:
          • Maggie Warrington, RN
          • Phone Number: 407-303-7556
      • Orlando, Florida, United States, 32806
      • Safety Harbor, Florida, United States, 34695
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Memorial Healthcare, Inc
        • Principal Investigator:
          • Thomas Noel, MD
        • Contact:
        • Sub-Investigator:
          • Pablo Rengifo, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Chandan Devireddy, MD
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
          • David Kandzari, MD
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Research Institute
        • Contact:
          • Donna Lahay
          • Phone Number: 470-793-4065
        • Principal Investigator:
          • Salvatore Mannino, MD
        • Sub-Investigator:
          • Amar Patel, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Maywood, Illinois, United States, 60153-3328
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Bruce Lewis, MD
          • Phone Number: 708-216-9447
        • Contact:
        • Principal Investigator:
          • Bruce Lewis, MD
      • Palos Park, Illinois, United States, 60464
        • Recruiting
        • Heart Care Centers of Illinois
        • Contact:
          • Ravi Ramana, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • St. Vincents Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50266-8209
        • Recruiting
        • Mercy Medical Center
        • Sub-Investigator:
          • Daniel Shivapour, MD
        • Principal Investigator:
          • Magdi Ghali, MD
        • Contact:
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • UM St. Joseph Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Ambinder, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Eric Secemsky, MD
          • Phone Number: 617-667-8800
        • Contact:
          • Jenifer Kaufman
          • Phone Number: 617-632-8956
        • Principal Investigator:
          • Eric Secemsky, MD
        • Sub-Investigator:
          • Brett Carroll, MD
        • Sub-Investigator:
          • Anna Krawisz, MD
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John Hospital
        • Principal Investigator:
          • Amir Kaki, MD
        • Sub-Investigator:
          • Theodore Schreiber, MD
        • Contact:
        • Contact:
      • Grand Rapids, Michigan, United States, 49503-2560
        • Recruiting
        • Spectrum Health Hospitals
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Saint Joseph Mercy Oakland
        • Principal Investigator:
          • Kiritkumar Patel
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shukri David, MD
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Metropolitan Heart and Vascular Institute (MHVI)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Whitbeck, MD
        • Sub-Investigator:
          • Daniel Dulas, MD
      • Saint Cloud, Minnesota, United States, 56303-1900
        • Recruiting
        • CentraCare Heart & Vascular Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacob Dutcher, MD
        • Sub-Investigator:
          • Wade Schmidt, MD
        • Sub-Investigator:
          • Yaga Saine
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • North Mississippi Medical Center
        • Contact:
        • Contact:
          • Kristin Eads, RD, BSN
          • Phone Number: 662-620-6875
          • Email: keads@nmhs.net
        • Principal Investigator:
          • Barry Bertolet, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Karen Deffenbacher, MD, PhD
          • Phone Number: 402-559-5151
        • Contact:
          • Nichole Coltrain, RN
          • Phone Number: 402 559-0232
        • Principal Investigator:
          • Karen Deffenbacher, MD, PhD
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
          • Dimitrios Karmpaliotis, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Mohamed Latib, MD
        • Sub-Investigator:
          • Maday Gonzalez, MD
      • Liverpool, New York, United States, 13088
        • Recruiting
        • SJH Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Ayman Iskander
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
          • Ian Dalangin
          • Phone Number: 516-562-2457
        • Contact:
          • Salome Elia Reddy
          • Phone Number: (516) 562-1385
        • Principal Investigator:
          • Avneet Singh, MD
      • New York, New York, United States, 10021-9800
        • Recruiting
        • Weill Cornell Medical Center
        • Contact:
        • Principal Investigator:
          • Dmitriy Feldman, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Campbell, MD
        • Sub-Investigator:
          • John A. Phillips, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Heart Hospital
        • Principal Investigator:
          • Mohammad Ghani
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • UPMC Harrisburg Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Bachinsky
        • Sub-Investigator:
          • Cleon Hubbard
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Debbie Cohen, MD
        • Sub-Investigator:
          • Taisei Kobayashi, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Principal Investigator:
          • Ramzi Khalil, MD
        • Contact:
          • Ramzi Khalil, MD
          • Phone Number: 412-359-4025
        • Contact:
          • Tracy Spirk
          • Phone Number: 412-359-4025
        • Sub-Investigator:
          • David Lasorda, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • South Carolina
      • Anderson, South Carolina, United States, 29621
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Pete Fong, MD
        • Contact:
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Centennial Medical Center
        • Principal Investigator:
          • Brian Jefferson, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bryan Doherty, MD
    • Texas
      • Dallas, Texas, United States, 75226-1316
        • Recruiting
        • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
        • Contact:
          • Robert Stoler, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alpesh Shah, MD
        • Sub-Investigator:
          • Neal Kleiman, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White The Heart Hospital Baylor Plano
        • Contact:
          • Srinivasa Potluri, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Hospital
        • Principal Investigator:
          • Jorge Alvarez, MD
        • Contact:
          • Aliseiya Garza, BS
          • Phone Number: 210-449-5026
        • Contact:
          • Maurene Cantu, RN
          • Phone Number: 210-218-4950
        • Sub-Investigator:
          • Abelardo Martinez-Rumayor, MD
        • Sub-Investigator:
          • Moises Bucay, MD
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas at Tyler
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frank Navetta, MD
        • Sub-Investigator:
          • Robert Smith, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kent Meredith, MD
        • Sub-Investigator:
          • Edward Miner, MD
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Rony Lahoud, MD
          • Phone Number: 802-847-3734
        • Contact:
        • Principal Investigator:
          • Rony Lahoud, MD
        • Sub-Investigator:
          • Dauerman Harold, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • UVA Medical Center
        • Contact:
          • Kelly Parker, RN, CCRC
          • Phone Number: 434-982-1058
        • Contact:
          • Linda Bryceland, RN, CCRC
          • Phone Number: 434-982-1058
        • Principal Investigator:
          • Kanwar Singh
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Medical Center Everett
        • Contact:
        • Contact:
          • Dean Rocco
        • Principal Investigator:
          • Mahesh Mulumudi, MD
        • Sub-Investigator:
          • Apurva Badheka, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
        • Principal Investigator:
          • Suhail Allaqaband, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fuad Jan, MD
        • Sub-Investigator:
          • Babak Haddadian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  3. Individual has an average systolic baseline home blood pressure ≥135 mmHg

Exclusion Criteria:

  1. Individual lacks appropriate renal artery anatomy
  2. Individual has undergone prior renal denervation
  3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  5. Individual has an estimated glomerular filtration rate (eGFR) of <45
  6. Individual has one or more episode(s) of orthostatic hypotension
  7. Individual is pregnant, nursing or planning to become pregnant
  8. Individual has primary pulmonary hypertension
  9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main Cohort: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Device: Renal Denervation (Symplicity Spyral™)
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Other Names:
  • Renal Denervation
  • Renal Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Time Frame: 6 months
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time subject's blood pressure is controlled
Time Frame: Procedure to 36 months post-procedure
Procedure to 36 months post-procedure
Office Systolic Blood Pressure change
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Home Blood Pressure change (Main Cohort Only)
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Change in blood pressure as measured by 24-hour ABPM
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Change in number of anti-hypertensive medications taken from baseline
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in EQ-5D quality of life score
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in hypertension health status score
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Evaluate pre-specified subgroups (Chronic Kidney Disease, Diabetes Mellitus Type II, etc) as predictors for change in blood pressure as measured by OBP, HBP and ABPM
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Evaluation of slope of eGFR
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Incidence of events, including major adverse events
Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
  • Principal Investigator: Felix Mahfoud, MD, Saarland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT20044RDN004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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Locations

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