Moderate Intensity Training in Patients With Truncating Genetic Variants in TTN.

NCT05180188 | Completed DMC

• 1 other identifier: 75682
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to investigate the effect of an 8-week moderate-intensity exercise program on aerobic fitness and cardiac contractility in patients with truncations of the sarcomeric protein titin.

Conditions

Cardiomyopathies; Truncation Mutation; TTN

Keywords

TTNtv mutation; Intensity training; Exercise; VO2 max; Cardiac output

Outcome Measures

Primary Outcomes (1)

• Difference in change in peak oxygen uptake (VO2peak) as measured in an incremental cycle-ergometer exercise test to exhaustion, in the placebo vs intervention period

  The VO2peak will be defined as the 20 consecutive seconds with the highest average VO2 during the incremental cycle-ergometer exercise test to exhaustion.

  8 weeks

Secondary Outcomes (14)

• Difference in change in left ventricular stroke volume at approximately 50% of maximal exertion in the placebo vs intervention period.

  8 weeks

• Change in blood volume with training.

  8 weeks

• Change in hemoglobin mass with training.

  8 weeks

• Difference in change in cardiac output at approximately 50% of maximal exertion in the placebo vs intervention period.

  8 weeks

• Difference in change in cardiac output at 100% of VO2peak, in the placebo vs intervention period.

  8 weeks

Study Arms (2)

Placebo periode

NO INTERVENTION

In the first study period, participants will not be exposed to any intervention and will be advised to not start any new medications, diets or participate in any activities which could influence their health.

Exercise periode

EXPERIMENTAL

In the second period, participants will perform regular moderate-intensity exercise 3 times/week.

Behavioral: Training

Interventions

Training BEHAVIORAL

In the 8-week training period, participants will have three training sessions with a duration of 30 minutes at 70% of VO2peak per week.

Exercise periode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Mutations in the TTN gene leading to truncating variants in cardiac expressed exons of titin.
• A clinical diagnosis of dilated cardiomyopathy or fulfulling criteria for the diagnosis of heart failure or hypokinetic non-dilated cardiomyopathy.

You may not qualify if:

• New York Heart Association functional class IV.
• Patients with a left ventricular assist device or who have had a heart transplant.
• Change in heart failure medications within the last month.
• CRT implantation within the last 6 months.
• Inability to perform exercise due to orthopedic or other non-cardiovascular limitations.
• Clinical history of exercise-induced syncope likely caused by ventricular tachyarrhythmias.
• Current participation in moderate or high intensity exercise exceeding 2.5 hours/per week.
• Inability to give informed consent.
• Pregnant women.
• Severe vascular disease (IE claudicatio intermittens).
• Severe valvular disease (moderate aortic stenosis/regurgitation or severe mitral regurgitation/stenosis).
• Life expectancy less than 12 months.
• Expected reduced compliance.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (35)

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MeSH Terms

Conditions

Cardiomyopathies; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• John Vissing, MD PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bach.med.

Model Details: The crossover trial has a two-period design. In the first study period, participants will not be exposed to any intervention and will be advised to not start any new medications, diets or participate in any activities which could influence their health. In the second period, participants will perform regular moderate-intensity exercise 3 times/week. Both study periods will last 8 weeks.

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: February 14, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)