To look in to the breathlessness caused by Heart

Phase 1

• Conditions: Heart failure with preserved left ventricular ejection fraction; MedDRA version: 14.1 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1 Level: HLT Classification code 10019283 Term: Heart failure signs and symptoms System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1 Level: HLT Classification code 10019281 Term: Heart failures NEC System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2006-001109-28-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2014-02-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Clinical features consistant with heart failure
LVEF>50%,with no evidence of significant valvular disease, no
hypertrophic cardiomyopathy, and no ebvidence of pericardial
constriction.
A peak VO2 of <80% predicted, with a pattern of gas exchange on
metabolic Exercise testing indicating a cardiac cause for limiktation.
In sinus rhythm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Abnormal liver function tests, pre-existing peripheral neuropathy,
concomitant use of amiodarone and women of childbearing potential,
objective evidence of lung disease on formal lung function tests

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test whether perhexiline improve exercise capacity (peak vo2) in patients with heart failure with preserved left ventricular ejection fraction(HFpEFsyndrome);Primary end point(s): Peak VO2;Timepoint(s) of evaluation of this end point: 6 months;<br> Secondary Objective: Improvement in :<br> Symptomatic status(modified minnesota living with heart failure<br> questionnaire)<br> Global LV ejection fraction(MRI),long axis systolic function,and radial<br> systolic function(MRI,ECHO,tissure doppler)<br> Peak exercise cardiac output<br> Resting and exercise myocardial energetics by cardiac MR spectroscopy<br> Resting and exercise diastolic function(nuclear studies)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Symptomatic status( Modified Minnesota living with heart failure<br> questionnaire)<br> Global LV ejection fraction,long axis systolic function, radial systolic<br> function(MRI, ECHO, tissure doppler)<br> Peak exercise cardiac outputdial<br> resting and exercise myocardial energetics by cardiac MR spectroscopy<br> Resting and exercise diastolic dysfunction(nuclear studies)<br> ;Timepoint(s) of evaluation of this end point: 6 months