Measurement of Endothelial Function and Cardiac Output: New Methods

June 9, 2016 updated by: Sebastian Beckmann, Charite University, Berlin, Germany

Pilot Study: Analysis of Endothelial Function Through Circulating Endothelial Cells and Puls-amplitude-tonometry and of Non-invasive Measurement of Cardiac Output on Exertion in Patients With Heart Failure, Pulmonary Hypertension, Arterial Hypertension and Diabetic Nephropathy

The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin

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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from the conditions stated above

Description

Inclusion Criteria:

  • Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
  • Signed consent form

HFpEF:

  • Baseline-Echocardiography:
  • hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or
  • BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or
  • LAVI > 28 ml/m² and E/E' > 8 or E' < 8cm/s or PAPsys > 40mmHg and E/E' > 8 or E' < 8 cm/s
  • Possibility to take part in cardiac stress test
  • Heart failure NYHA I-III
  • Sinus rhythm
  • Max. O2-uptake on exertion < 20ml/kgBW/min

HFrEF

  • HFrEF due to ischemic or non-ischemic reasons
  • NYHA I-III
  • Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)
  • EF <=45%, Simpson Biplan PH
  • NICE-Classification 2013 I/II
  • PAH >= 25 mmHg
  • Precapillary PAH: Wedge-pressure <= 15 mmHg, CO normal or low
  • Postcapillary PAH: Wedge-pressure >= 15 mmHg, CO normal or low

Diabetic nephropathy:

  • Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
  • Diabetic nephropathy has been diagnosed before (anamnesis)
  • Macroalbuminuria: Urine Albumine/Creatinine-ratio > 300mg/g Creatinine (>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR <90ml/min/1.73m² (CKD-EPI)
  • Microalbuminuria: 30-300mg/g Creatinine (>=3.4 mg/mmol but <34mg/mmol) tested as above and GFR < 90 ml/min/1.73m² and diabetic retinopathy

AH:

  • Hypertension diagnosed at least 6 months except structural heart disease: EF > 55% and no sign of HFpEF
  • No symptoms of coronary heart disease
  • Possibility to take part in cardiac stress test
  • Stable pharmacologic therapy of Hypertension for at least 4 weeks
  • Systolic blood pressure <140 mmHG during Screening

Exclusion Criteria:

  • Patient incapable of contracting
  • Angina pectoris > CCS II
  • Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
  • Myocardial infarction in the last 3 months
  • Stroke in the last 3 months
  • Valvular heart disease > II°
  • Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
  • Congenital complex heart disease
  • Active myocarditis
  • Significant lung disease
  • Significant Cardiac dysrhythmia
  • Scheduled changes in medication during time of study
  • (Scheduled) heart transplant
  • Cardiac resynchronisation therapy over the last three months
  • ICD/Pacemaker-implant in the last 4 weeks
  • Uncontrolled Hyper/Hypotension (>180mmHg, <95mmHg)
  • Patient taking part in Rehabilitation program
  • Diagnosed Malignant disease or disease with life expectancy < 1 year
  • Anemia with Hb<10mg/dl
  • Untreated significant thyroid disease

HFpEF, Hypertension and PH:

  • Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
  • Significant changes in cardiovascular Status over the two weeks of study
  • Instable cardiopulmonary Status over the last four weeks

HFrEF:

  • I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
  • Myocardial infarction in the last 4 weeks

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFpEF
patients with heart failure with preserved ejection fraction
Device: Endo-PAT
Analysis of endothelial function through pulse-amplitude-tonometry
Device: NICOM
Non-invasive measurement of cardiac output
HFrEF
patients with heart failure with reduced ejection fraction
Device: Endo-PAT
Analysis of endothelial function through pulse-amplitude-tonometry
AH
patients with hypertension
Device: Endo-PAT
Analysis of endothelial function through pulse-amplitude-tonometry
Device: NICOM
Non-invasive measurement of cardiac output
Nephropathy
patients with diabetic nephropathy
Device: Endo-PAT
Analysis of endothelial function through pulse-amplitude-tonometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Test-retest-reliability EndoPAT
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-retest-reliability circulating endothelial cells
Time Frame: 2 weeks
2 weeks
Test-retest-reliability NICOM
Time Frame: 2 weeks
2 weeks
Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test
Time Frame: 2 weeks
2 weeks
Correlation: circulating endothelial cells and EndoPAT and endothelial function
Time Frame: 2 weeks
will include the molecular diagnostic of circulating endothelial cells
2 weeks
Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome
Time Frame: 2 weeks
2 weeks
Correlation cardiac Output on exertion and echocardiography in HFpEF
Time Frame: 2 weeks
2 weeks
Clinical feasibility of circulating endothelial cells and EndoPAT
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer
Health Twist GmbH

Investigators

  • Study Chair: Hans-Dirk Duengen, PD Dr. med., Charite Universitaetsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-CEC

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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