Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF) (DIAMONDHFpEF)

February 8, 2017 updated by: University of Leicester

Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction

The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF and healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:

  1. better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
  2. provide mechanistic insights into pathophysiology
  3. describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)

Study Type

Observational

Enrollment (Actual)

280

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with heart failure from Hospital (including ward patients and out-patients clinic)

Description

Inclusion Criteria:

  • Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm)

Exclusion Criteria:

  • Myocardial infarction within the preceding 6 months
  • Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative)
  • Suspected or confirmed constrictive pericarditis
  • Significant native valve disease (≥ moderate severity)
  • Known Significant lung disease (documented or FEV1< 30% or FVC < 50%)
  • Non-cardiovascular co-morbidity likely to cause death within 6 months (e.g. malignancy)
  • Significant renal failure (estimated GFR < 30 ml/min/m2)
  • Patient inability to provide informed consent (e.g. dementia)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFpEF group
clinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography
Diagnostic test: MRI scan, Echo scan
Other Names:
  • cardiac MRI, trans thoracic echocardiography
HFrEF group
Clinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography
Diagnostic test: MRI scan, Echo scan
Other Names:
  • cardiac MRI, trans thoracic echocardiography
Healthy control group
Asymptomatic controls (age and sex-matched) without known heart disease
Diagnostic test: MRI scan, Echo scan
Other Names:
  • cardiac MRI, trans thoracic echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure
Time Frame: Minimum 6 month follow-up
Minimum 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of new clinical diagnoses detected by cardiac MRI
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Exercise capacity as assessed by the six-minute walk test
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

University of Leicester

Collaborators

National Institute for Health Research, United Kingdom

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

February 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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