Effect of Acute Hypoxia on RIght VEntRicular Function in Asthma.

NCT07431580 | Recruiting

• 1 other identifier: RIVER-Asthma
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland. At high altitude, less oxygen is available, which places stress on the body-particularly on the heart, which has to pump blood through the lungs. How the heart, especially the right ventricle, in people with asthma responds to this stress is still not well understood. Therefore, this study investigates how the heart responds to simulated altitudes of 2,500 m and 4,000 m, both at rest and during light physical activity in patients with asthma. The primary objective is to assess how right ventricular function changes under conditions of reduced oxygen availability. In addition, vital signs, changes in blood gases, oxygen levels in blood and tissue and shortness of breath are assessed. The "altitude" is simulated using a special gas mixture that participants inhale. Participants undergo three altitude conditions (490, 2,500, and 4,000 m above sea level). The order of the altitude conditions is assigned at random. The aim is to better understand how the right ventricle and other parameters respond to low-oxygen conditions and how affected patients can be better supported in the future.

Conditions

Right Ventricular Function; Hypoxia, Altitude; Hypoxia; Normobaric Hypoxia

Keywords

right ventricular free wall strain; RVFWS; right ventricular function; tissue oxygenation; breathing difficulty; blood gas; heart rate

Outcome Measures

Primary Outcomes (1)

• Right ventricular free wall strain

  The primary endpoint is defined as the right ventricular free wall strain (RVFWS) from condition normobaric normoxia to condition 4000m for group 1 and from normobaric normoxia to condition 2500m for group 2 at rest. RVFWS will be measured by speckle tracking strain analysis according to the guidelines of the European Association of Cardiology. Speckle tracking echocardiography allows to assess the right ventricular volume and true global RV function without relying on geometric assumption and is a valuable clinical bedside tool for assessing myocardial strain. Tomtec software (Philipps) will be used.

  It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.

Secondary Outcomes (19)

• Tricuspid annular plane systolic excursion (TAPSE)

  It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.

• Right ventricular-arterial coupling

  It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.

• RV/PA

  It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.

• Stroke volume

  It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.

• Heart rate

  It will be assessed at baseline and continuously measured during each condition (1 hour resting period and during the 10 minutes cycling).

Study Arms (6)

Arm ABC (normobaric normoxia - normobaric hypoxia 2500m - normobaric hypoxia 4000m)

OTHER

The participant receives first normobaric normoxia (A), then normobaric hypoxia equal to 2500 m.a.s.l. (B) then normobaric hypoxia representing 4000 m.a.s.l. (C). Condition A represents the control.

Other: Normobaric Hypoxia

Arm ACB (normobaric normoxia - normobaric hypoxia 4000m - normobaric hypoxia 2500m)

OTHER

The participant receives first normobaric normoxia (A), then normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric hypoxia equal to 2500 m.a.s.l. (B). Condition A represents the control.

Other: Normobaric Hypoxia

Arm BAC (normobaric hypoxia 2500m - normobaric normoxia - normobaric hypoxia 4000m)

OTHER

The participant receives first normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric normoxia (A), then normobaric hypoxia representing 4000 m.a.s.l. (C). Condition A represents the control.

Other: Normobaric Hypoxia

Arm BCA (normobaric hypoxia 2500m - normobaric hypoxia 4000m - normobaric normoxia)

OTHER

The participant receives first normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric normoxia (A). Condition A represents the control.

Other: Normobaric Hypoxia

Arm CAB (normobaric hypoxia 4000m - normobaric normoxia - normobaric hypoxia 2500m)

OTHER

The participant receives first normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric normoxia (A), then normobaric hypoxia equal to 2500 m.a.s.l. (B). Condition A represents the control.

Other: Normobaric Hypoxia

Arm CBA (normobaric hypoxia 4000m - normobaric hypoxia 2500m - normobaric normoxia)

OTHER

The participant receives first normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric normoxia (A). Condition A represents the control.

Other: Normobaric Hypoxia

Interventions

Normobaric Hypoxia OTHER

Normobaric hypoxia according to 408m (control/normobaric normoxia), 2500 m and 4000 m above sea-level at rest for 1 hour and at low intensity cycling for 10 minutes (5 min 30 W, 5 min 60 W).

Also known as: rest, low intensity cycling, normobaric normoxia

Arm ABC (normobaric normoxia - normobaric hypoxia 2500m - normobaric hypoxia 4000m); Arm ACB (normobaric normoxia - normobaric hypoxia 4000m - normobaric hypoxia 2500m); Arm BAC (normobaric hypoxia 2500m - normobaric normoxia - normobaric hypoxia 4000m); Arm BCA (normobaric hypoxia 2500m - normobaric hypoxia 4000m - normobaric normoxia); Arm CAB (normobaric hypoxia 4000m - normobaric normoxia - normobaric hypoxia 2500m); Arm CBA (normobaric hypoxia 4000m - normobaric hypoxia 2500m - normobaric normoxia)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Diagnosed and well controlled asthma bronchiale
• years (age group young: 18-39.99 years / age group older: 40-80 years)
• All sex and genders
• Living \<800m and without altitude exposure \> 2500 m and \> 24h within the last three weeks

You may not qualify if:

• \<18, \>80 years old
• Any other diagnosed cardiopulmonary condition including past HAPE
• Other clinically significant severe concomitant disease states (e.g. renal, hepatic dysfunction, etc.)
• Inability to follow the procedures of the study due to language problems, psychological neurological disorders or orthopaedic disorders
• Participants permanently living \>800m and altitude exposure \> 2500 m and \>24h within the last three weeks
• Pregnancy: Participants will be asked if pregnant or not, no screening for undetected pregnancy
• Lactating women
• Participation in other study with active treatment

Sponsors & Collaborators

• Mona Lichtblau: lead

Study Sites (1)

Consultant Clinic of Pulmonology, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Altitude Sickness; Hypoxia; Dyspnea

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mona Lichtblau

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Lichtblau, PD Dr. med.

CONTACT

+41 442552220; mona.lichtblau@usz.ch

Carmen Wick, Cand. PhD

CONTACT

+41 43 253 44 05; carmen.wick@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Single-center, double-blind, randomized controlled, cross-over study.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CH (1)