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

Healthy Controls Group - Age and Sex-matched Clinical Trial

— DIAMONDHFpEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050593
• Other study ID #: 0328
• Status: Completed
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 8, 2017
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Controls Group - Age and Sex-matched
• Heart Failure
• Patients With Heart Failure and Preserved Ejection Fraction - HFpEF
• Patients With Heart Failure With Reduced Ejection Fraction - HFrEF

Intervention

Diagnostic Test:
• MRI scan, Echo scan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	National Institute for Health Research, United Kingdom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite end-point of all-cause mortality or repeat hospitalisation with heart failure		Minimum 6 month follow-up
Secondary	The number of new clinical diagnoses detected by cardiac MRI		Through study completion, an average of 1 year
Secondary	Exercise capacity as assessed by the six-minute walk test		Through study completion, an average of 1 year
Secondary	Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire		Through study completion, an average of 1 year