Health TrialsbyHealthPanel

Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

ConditionsHeart Failure With Preserved Ejection FractionRenal Denervation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorXinjiang Medical University

About this trial

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signs or symptoms of heart failure;

normal or mildly abnormal systolic LV function (LVEF ≥ 50%);

evidence of diastolic LV dysfunction.

Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement).

Disqualifiers

Known secondary cause of hypertension

Anatomy not eligible for renal denervation

Systolic heart failure (LVEF < 50%)

Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham procedure and maintenance of heart failure medications

    Procedure/Surgery

    Sham intervention, maintenance of heart failure medications

  • Renal denervation and maintenance of heart failure medications

    Procedure/Surgery

    Renal denervation and maintenance of heart failure medications

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Renal denervation and maintenance of heart failure medicationsExperimental treatment 1 intervention
Group B: Sham intervention, maintenance of heart failure medicationsSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline E/E' at 12 months

Echocardiography will be used to measure the E/E'

Time frame
12 months after treatment

Secondary outcomes

1

Number of participants with adverse events

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinjiang Medical University

Lead sponsor

First Affiliated Hospital of Xinjiang Medical University

Sponsor institution

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Source ClinicalTrials.gov
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