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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00839228
Other study ID # RRK 3147
Secondary ID RRK 3147MREC 08/
Status Completed
Phase Phase 2
First received February 6, 2009
Last updated November 4, 2015
Start date March 2009
Est. completion date February 2014

Study information

Verified date November 2015
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

Up to half of all patients with clinical features of heart failure are found to have normal heart pumping function. Recently the investigators have shown that a drug called perhexiline markedly improved exercise capacity and symptoms in patients with heart failure associated with impaired cardiac pump function. In this proposal the investigators will assess whether perhexiline has beneficial effects in patients with heart failure and a normal heart pumping function.


Description:

Up to 50% of patients with symptoms of heart failure have a preserved left ventricular ejection fraction (HFpEF syndrome). Current therapy for systolic heart failure is targeted at inducing vasodilation and counteracting neuro-endocrine activation. There is a lack of a corresponding evidence base for the treatment of HEpEF. We have previously shown that perhexiline, an agent that increases the efficiency of energy production by shifting substrate utilization from free fatty acids towards glucose, was highly effective in improving exercise capacity, symptoms and cardiac function in patients with systolic heart failure. We have also recently shown that energy deficiency plays a major role in the pathophysiology of HFpEF. In this proposal we therefore aim to investigate the effectiveness of perhexiline in 70 HFpEF patients, in a 3 month randomised, double-blind, controlled trial. An interim analysis is planned after 20 patients.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 90 Years
Eligibility Inclusion Criteria:

- HFpEF will be defined as:

- Clinical features consistent with heart failure

- LVEF = 50%, with no evidence of significant valvular disease

- No hypertrophic cardiomyopathy, and no evidence of pericardial constriction

- Peak VO2 < 80% predicted, with RER>1 and with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation)

- Patients recruited will be in sinus rhythm

Exclusion Criteria:

- BMI >35

- Objective evidence of lung disease on formal lung function testing

- Reversible myocardial ischaemia on contrast-enhanced myocardial stress Echocardiography, and no evidence of exercise-induced mitral regurgitation (>2+)

- Impaired hepatic function; known hypersensitivity to perhexiline

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Perhexiline
100mg o bd for 3 months
Placebo
Placebo one tablet bd for 3 months

Locations

Country Name City State
United Kingdom University of Aberdeen Aberdeen

Sponsors (1)

Lead Sponsor Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Peak oxygen consumption (Vo2max) 3 months No
Secondary Symptomatic Status (Modified Minnesota Living with Heart Failure Questionnaire) 3 Months No
Secondary Resting myocardial energetics by cardiac MR spectroscopy (MRS) 3 months No
Secondary Resting and exercise diastolic function (nuclear studies) 3 months No
Secondary Indirect measures of resting LVEDP (tissue Doppler E/Ea) 3 months No
Secondary Global LV Ejection Fraction (MRI / nuclear studies) 3 months No
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