Mechanisms of Altered Ventilatory Control in Heart Failure

NCT02421341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-12-16

No results posted yet for this study

Summary

This study is being done because the investigators are trying to understand how feedback from the muscles can influence your blood pressure and breathing during exercise, and if the investigators can reduce this response in heart failure patients. The investigators are also trying to determine ways to improve tolerance to exercise in heart failure patients.

Conditions

Interventions

DRUG

Fentanyl

During study visits 2 and 3 you will receive an intrathecal (fluid filled space surrounding the spinal cord) injection of either fentanyl or placebo (saline). Fentanyl is an opiate (narcotic) drug and a common medication, however the way fentanyl is being used in this study is considered investigational.

PROCEDURE

Catheters

A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.

OTHER

Exercise

You will be asked to exercise, ride a stationary bike, at maximal exertion.

RADIATION

DEXA

During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.

OTHER

Pulmonary Function Tests

During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.

OTHER

Blood Draw

You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.

OTHER

Chemosensitivity Test

Using a bag you breath in and out your own air.

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Thomas Olson, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2019-06-21
Completion
2019-06-21

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421341 on ClinicalTrials.gov