NCT04502121: ValvEx

Preoperative Optimization of Cardiac Valve Patients' Expectations

Completed NA Last updated 21 September 2023

What this trial tests

NA trial testing EXPECT: Preoperative optimization of cardiac valve patient's expectations in Cardiac Valve Disease in 89 participants. Completed in 7 July 2023.

Timeline

17 July 2020

Primary endpoint
29 November 2022

7 July 2023

Quick facts

Lead sponsor	Philipps University Marburg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	89
Start date	17 July 2020
Primary completion	29 November 2022
Estimated completion	7 July 2023
Sites	1 location across Germany

Drugs / interventions tested

• EXPECT: Preoperative optimization of cardiac valve patient's expectations

Conditions studied

• Cardiac Valve Disease — all drugs for Cardiac Valve Disease →

Sponsor

Philipps University Marburg

Who can join

18 and older, any sex, with Cardiac Valve Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preoperative optimization of cardiac valve patients' expectations: Study protocol of the randomized controlled ValvEx-trial.
   Horn N, Gärtner L, Rastan AJ, Andrási TB, et al · · 2023 · cited 5× · PMID 36937912 · DOI 10.3389/fcvm.2023.1105507
2. Effects of a preoperative psychological expectation-focused intervention in patients undergoing valvular surgery - the randomized controlled ValvEx (valve patients' expectations) study.
   Horn N, Gärtner L, Rastan AJ, Andrási TB, et al · · 2025 · cited 1× · PMID 39827935 · DOI 10.1016/j.ahj.2025.01.006